FDA Roundup: April 11, 2023

FDA News Release

• For Immediate Release: April 11, 2023

Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: 

• On Monday, the FDA authorized for marketing the MISHA Knee System, an implant placed alongside the knee joint to help reduce the amount of load carried by part of the joint. Unlike conventional knee replacement, the knee joint is not removed with this device. The MISHA Knee System is indicated for patients with osteoarthritis of certain parts of the knee who have failed to find relief with surgical or non-surgical treatment and are still experiencing pain that interferes with activities of daily living. These patients are also unwilling to undergo or are ineligible for total knee replacement due to age or absence of advanced osteoarthritis.
• On Monday, the FDA, in partnership with the Substance Abuse and Mental Health Services Administration (SAMHSA) and the Reagan-Udall Foundation for the FDA, announced a virtual public meeting on May 10-11 titled, Considerations for Buprenorphine Initiation and Maintenance Care. The meeting will include stakeholders — including people who use drugs, their families and community, harm reduction programs, health professionals from inpatient and outpatient settings, academic researchers, and federal partners — and will explore real-world experiences and scientific evidence for buprenorphine initiation strategies as well as medication dosing and management during continued treatment across different care settings.
• COVID-19 testing updates: 
  • As of today, 446 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 300 molecular tests and sample collection devices, 84 antibody and other immune response tests, 61 antigen tests, and one diagnostic breath test. There are 78 molecular authorizations and one antibody authorization that can be used with home-collected samples. There is one EUA for a molecular prescription at-home test, two EUAs for antigen prescription at-home tests, 28 EUAs for antigen over-the-counter (OTC) at-home tests, and five for molecular OTC at-home tests.
  • The FDA has authorized 46 antigen tests and eight molecular tests for serial screening programs. The FDA has also authorized 1345 revisions to EUA authorizations.